Status:
COMPLETED
Efficacy and Safety of Zenoctil in Reducing Body Weight
Lead Sponsor:
InQpharm Group
Conditions:
Overweight
Eligibility:
All Genders
18-60 years
Phase:
PHASE3
Brief Summary
The intention of the study is to evaluate the safety and potential body weight and body fat loss effects of a 12-week treatment with Zenoctil in a randomized, double-blind, placebo-controlled, paralle...
Eligibility Criteria
Inclusion
- Caucasian males and females, age 18 to 60 years
- 25 kg/m2 ≤ BMI ≤32 kg/m2
- Expressed desire for weight loss
- Accustomed to 3 main meals a day
- Consistent and stable body weight 3 months prior to study enrollment
- Commitment to avoid the use of other weight loss products/programs during the study
- Commitment to adhere to diet recommendation
- Females' agreement to use appropriate birth control methods during the active study period
- Subject declares in writing his/her consent to participate, understands requirements of the study and is willing to comply
Exclusion
- Known sensitivity to Garcinia cambogia, Lagerstroemia speciosa (other members of Lythraceae family), caffeine, tannins
- History of diabetes mellitus or other endocrine disorders
- Fasting blood glucose \>7 mmol/L
- Treatment with systemic corticosteroids within the last 12 months
- Current use of antidepressants
- Uncontrolled hypertension (\>160/110) or other uncontrolled cardiac, pulmonary, renal, or liver disease, determined to be clinically significant by the investigator
- Presence of acute or history of chronic gastrointestinal disease
- Schizophrenia or other diagnosed psychiatric disorders
- Any other acute or chronic disease or any other medical condition which, in the investigator's view, may preclude subject's inclusion (e.g., cancer, HIV)
- Bariatric surgery
- Abdominal surgery within the last 6 months
- History of eating disorders like bulimia, anorexia nervosa
- Changes in the dose of estrogen, contraceptives or thyroid hormone within the last 3 months
- Pregnancy or nursing
- Any medication or use of products for the treatment of obesity (e.g., fat binder, carbohydrate blocker/starch blocker, fat burner, satiety products etc.) within the last 6 weeks
- More than 3 hours strenuous sport activity per week
- History of abuse of drugs, alcohol or medication
- Smoking cessation within the 6 months prior to this study
- Incompliance due to language difficulties
- Participation in another study during the last 4 weeks
- Clinically relevant excursions of safety parameters
Key Trial Info
Start Date :
July 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
92 Patients enrolled
Trial Details
Trial ID
NCT01423617
Start Date
July 1 2011
End Date
December 1 2011
Last Update
April 23 2015
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Barbara Grube
Berlin, Germany